Is Your Supply Chain Capable of delivering Clinical Trials On Time

You just identified a new compound that is worthy of an Investigational New Drug (IND) designation and making it through clinical trials. Now, you need to determine if your clinical supply chain capable of delivering the goods? It's important to examine your supply chain in order to make sure it delivers on time, efficiently, and with quality, all within your budget. Many emerging biopharmaceuticals may not have the capabilities to meet these challenges.

Hidden dangers of a fragmented oversight system

Everything is interdependent in clinical trials. This includes manufacturing, packaging and labeling as well as distribution. It is crucial to have proper oversight and accurate information in order to avoid cascading failures along your timeline.

Companies will often choose to pursue the best-of-breed approach when recruiting supply chain partners. They opt for specialists in each task mentioned above. This approach may not reduce risk but can actually increase it. It can lead to misunderstandings as to who is responsible. The sheer cost of clinical trials in pharma and the potential impact on human lives raises the stakes.

People like to say that they've done all the math. I have a hundred patients. Each patient takes 10 doses. That means I have to order a thousand units. We're done, right?' Wrong."

Fragmented oversight can also cause short-term thinking. Companies that are not part of a larger company have little incentive or motivation to adapt their processes in order to make it work for another company. For example, if the label language is not finalized in time, the printer or translation company may not be able speed up their work. As long as the contract terms are met, the sponsor has no recourse or leverage. Fragmented oversight can increase financial risk because it doesn't allow partners enough visibility into the timing of services that are further out at lower costs.

Fragmented supply chain oversight can make it difficult for patients to comply. Patients may not understand the dosing instructions, which may make it difficult for them to use their data.

Strategy 1

You might consider a supply partner for clinical trials who can handle all aspects of your supply chains or has experience managing supply chains partners. This will help you meet your quality and speed goals.

Is your "end-to-end" oversight really early-middle-to-late-middle oversight?

Although the challenges associated with clinical trial supply may seem small compared to the development peaks, they are complex and interrelated to all that has gone before. Many common supply chain problems are caused or augmented by decisions made in pre-clinical research. It will be difficult for clinical trial supply partners to collaborate with early-stage investigators in order to guide decisions that support steady trial progress. Take, for example:

The impact of formulation on packaging, dosing, shipping, and storage can be dramatic.

To avoid any last-minute delays, label text creation and translation can be done before the final compound form is created.

It is possible to avoid any downstream customs problems by understanding how drugs are classified in different countries and the regulations regarding shipping while they are still at the sourcing phase.

It is possible to save significant money by coordinating dose packaging and shipping containers at an early stage of the process, especially when it comes to cold chain therapies.

It is possible to reduce shipping and ancillary costs by looking for more competitive suppliers earlier.

If your clinical supply partner can't seamlessly integrate with your drug developers team in time to make an impact, then their claims that they have end-to-end oversight should not be taken seriously.

Strategy 2

To get critical downstream tasks started sooner, consider partnering with a company that supplies clinical trials.

Multiple supply chain partners: Are they increasing security or decreasing it?

Pop quiz: Which introduces greater risk to your clinical trial's success?

A: Working with individuals who are experts in labeling, packaging, distribution, and other related areas.

B: Working with one or two partners in order to manage everything

Many would quickly respond that B increases risk. They cite the "all my eggs are in one basket" school. This is one of the biggest business mistakes of modern times. Complex supply chains can be simplified by fewer links. More links do not increase complexity. However, more links can increase risk. Let's take a look at the practical implications of this.

Downside risks:

Although a supply chain that includes specialists sounds great, it can increase your risk in at most four ways.

Upstream companies are not held accountable for their downstream activities. This makes it difficult for them to go beyond what they have agreed to do to solve any issues that may arise later. Different methods or definitions of the same terms can lead to delays and confusion. Handoffs between companies can also lead to mistakes, oversights and liabilities.

Any slowdown may cause ripples downstream that could lead to you missing your appointment with another specialist provider.

Upside risks:

Long supply chains limit upside potential. Each company that you work with will require a contract to be negotiated, an integrated system, and oversight from someone within your organization. It will increase the cost and time required to manage these tasks, which can make it more expensive and slow. A long chain eliminates the possibility to pool supplies between projects, link databases across phases, or earlier sharing information to speed up downstream processing.

Another take:

Working with a few larger companies who are specialists in the supply chain for clinical trials can help reduce risk. Global partners will have multiple locations, which can add redundant capabilities and global storage options to speed shipping. They may even be able to offer currency or tax savings through leveraging operations in other regions. A short supply chain means that the same company is responsible for all or most of the processes. This gives them a strong incentive and incentive to lower cost and complexity and to proactively address issues before they arise.

Strategy 3

You might consider working with a supply partner for clinical trials who can help reduce risk by having multiple locations across several regions.

A strategy to keep everything under control

No matter whether you choose a short or long supply chain strategy, there will always be multiple partners to coordinate as there are many facets to a clinical study. You will likely have a CRO to manage the trial, a CDMO for manufacturing the therapy, and a clinical supply expert to link them to investigators, patients, and trial sites.

Although each partner can be trusted in their respective roles, mistakes are common where they meet. Even if everyone is paying attention, different approaches from companies with different priorities can lead to problems. As mentioned, every aspect of a clinical trial depends on each other.

To manage expectations and maintain compliance, the CRO will need to have insight into drug flow to sites or patients.

The CDMO must know if product is in short supply and if they should plan to restart production. To ensure that all parties are happy with product and information, the Clinical Trial Supply Company will need to work in coordination with the CRO/CDMO.

Although a robust Interactive Response Technology platform (IRT), can help you reach your milestones, it does have its limitations. Although user acceptance testing can confirm that the system works as you expect, it is equally important to make sure the platform is correctly programmed to handle key functions like randomization, per patient inventory management and information sharing. Without real-time feedback, forecasting is impossible. An IRT is not the ultimate answer, no matter how sophisticated it may be. Software cannot correct any errors in the study and will not allow you to adjust your course.

A single Clinical Supply Chain Manager is essential to ensure that your trial runs smoothly. This manager will have oversight over the entire manufacturing process. Your manager will be able to integrate labeling and packaging, distribution, dosing patients, and data collection activities with this frame of reference. Your manager should be familiar with IRT setup as it is essential for IRTs to function according to their fundamental principles. This will ensure that your program meets all requirements and is properly programmed. To ensure that the trial's human side is represented and managed properly, the partner should also be knowledgeable in the use of clinical sites.

Conclusion

The goal of clinical supply chain management is to minimize risk, cost, time, and delay. Some companies may believe that you must sacrifice one in order to obtain the other.?